Sun Pharma Gains on Anti-Diabetes Drug Approval
Sun Pharma announces US FDA approval for generic Glumetza
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Sun Pharmaceutical Industries Ltd. announced that one of its subsidiaries received the final approval from the U.S. Food and Drug Administration for launching generic versions of anti-diabetic drug Glumetza.
The FDA approved the Abbreviated New Drug Application for Metformin Hydrochloride extended release tablets 500 mg and 1,000 mg, Sun Pharma said in its press release. The commercial launch of these tablets in the U.S. is expected over the next few weeks, the company added.
Metformin Hydrochloride extended release tablets are the therapeutic equivalents of Santarus Inc.’s Glumetza tablets and are used in the treatment of diabetes. The tablets have annual sales of approximately $1.2 billion in the U.S., according to the IMS data cited by Sun Pharma.
Lupin’s Loss Is Sun Pharma’s Gain
Lupin Ltd.’s 180-day exclusivity for Glumetza ended on July 30, 2016, opening the doors for rivals like Sun Pharma to launch their own generic versions. Lupin had launched generic Glumetza with 180-day exclusivity on February 1, 2016.
The Sun Pharma stock rose as much as 1.4 percent to Rs 848 after the announcement.